BEUDAMED
    FDA Recall Terminated

    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.

    Recall: Z-0563-2011 · Initiated November 2, 2010

    Recall

    Recall Number
    Z-0563-2011
    Event Number
    57241
    Firm
    Terumo Cardiovascular Systems Corporation
    FEI Number
    1828100
    Product Code
    JOR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2010
    Posted
    December 8, 2010
    Terminated
    October 19, 2011
    Address
    6200 Jackson Road, Ann Arbor, MI, 48103-9586

    Description

    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.

    Reason

    The system 8000 roller pumps may fail resulting in a persistent pump stop.

    Action

    The firm sent "URGENT MEDICAL DEVICE CORRECTION" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORM Please note that we are not recommending that you stop using the roller pumps for your Sarns system 8000. For any questions, call toll free 800-262-3304 or phone 734-663-4145.

    Distribution

    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.

    Quantity

    95 devices both products